Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel

NCT ID: NCT02309554

Last Updated: 2016-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-03-31

Brief Summary

This post coital test study is a Phase I multi-center, randomized, crossover, non-significant risk device study to be carried out at two clinical sites/centers. The products to be tested are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of product use, with a goal of 10 participants completing the study.

Detailed Description

Each participant will be seen in approximately nine visits, over a period of 6-8 months, and will be contacted approximately 7 days after the final visit. Volunteers will be consented at Visit 1 and undergo procedures to confirm they are eligible to continue in the study.

Each participant will undergo four postcoital test (PCT) cycles:

1. The first PCT cycle will be a baseline cycle, done without the use of any product, in order to demonstrate the participant's ability to undergo normal ovulatory events and to produce receptive, midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating the cervical mucus is also evaluated in this cycle.

2. Test PCT cycles will be carried out during the subsequent menstrual cycles using either the SILCS diaphragm with 3% N-9, the SILCS diaphragm with ContraGel, or the SILCS diaphragm alone following a sequence of randomized treatment. Cycles may need to be repeated depending on the characteristics of the cervical mucus and the number of sperm found in the vaginal pool and endocervical specimens.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SILCS Diaphragm alone

Participants will complete a post-coital test cycle with SILCS diaphragm alone.

Group Type: ACTIVE_COMPARATOR

SILCS diaphragm

Intervention Type: OTHER

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring

SILCS Diaphragm with 3% Nonoxynol-9 Gel

Participants will complete a post-coital test cycle with SILCS diaphragm used with 3% nonoxynol-9 gel.

Group Type: ACTIVE_COMPARATOR

SILCS diaphragm used with 3% Nonoxynol-9

Intervention Type: OTHER

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. 3% Nonoxynol-9 (branded as Gynol II) is clear, unscented water soluble greaseless gel packed in plastic tubes with a vaginal applicator.

SILCS diaphragm

Intervention Type: OTHER

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring

SILCS Diarphragm with ContraGel

Participants will complete a post-coital test cycle with SILCS diaphragm used with ContraGel.

Group Type: EXPERIMENTAL

SILCS diaphragm used with ContraGel

Intervention Type: OTHER

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. ContraGel is a clear, water soluble greaseless gel packed in a metal tube.

SILCS diaphragm

Intervention Type: OTHER

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring

Interventions

SILCS diaphragm used with ContraGel

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. ContraGel is a clear, water soluble greaseless gel packed in a metal tube.

Intervention Type: OTHER

SILCS diaphragm used with 3% Nonoxynol-9

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. 3% Nonoxynol-9 (branded as Gynol II) is clear, unscented water soluble greaseless gel packed in plastic tubes with a vaginal applicator.

Intervention Type: OTHER

SILCS diaphragm

SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18-45 years, inclusive

2. General good health, by volunteer history and per investigator judgment

3. History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report

4. History of Pap smears and follow-up consistent with standard medical practice as outlined in the Study Manual or willing to undergo a Pap smear at Visit 1

5. Willing to abstain from intercourse and use of vaginal products as required in the protocol

6. Willing to use non-spermicidal, lubricated condoms from the first day of each menstrual cycle until 72 hours before expected midcycle

7. In a mutually monogamous relationship for at least the last four months with a male partner who: 7a. Is at least 18 years old; 7b. Has no known risk for STIs; 7c. Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements; and 7d. Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol

8. Protected from pregnancy by female tubal sterilization

9. Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection

10. Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol

Exclusion Criteria

1. History of hysterectomy

2. Vasectomy in male partner

3. Sterility or known history of sperm dysfunction in male partner

4. Currently pregnant or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome

5. Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera in the last 120 days

6. Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study

7. Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge)

8. Device does not appropriately fit volunteer, as determined by clinician

9. Inability to insert, position, and/or remove study device, by clinician or volunteer

10. History of sensitivity/allergy to 3% N-9, latex, ingredients in ContraGel, or silicone, for either the volunteer or her male partner

11. In the last six months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility

12. Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis

13. Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection

14. Positive test for HIV

15. Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)

16. Known current drug or alcohol abuse which could impact study compliance

17. Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study

18. History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days

19. Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her male partner which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

CONRAD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Center, Eastern Virginia Medical School

Norfolk, Virginia, United States

ProFamilia

Santo Domingo, , Dominican Republic

Countries

United States; Dominican Republic

Other Identifiers

A13-126

Identifier Type: -

Identifier Source: org_study_id